21 CFR Part 806:

21 CFR Part 806:

Medical Devices; Reports of
Corrections and Removals
Medical Devices; Reports of
Corrections
Kennethand Removals
C. Millen
LeadKenneth C. Millen
Compliance Officer
Lead Compliance
Division OfficerA
of Enforcement
Division
Office of
of Enforcement
Compliance A
Office of Compliance
Recall Reporting Requirements

 Objective
 Toreview the requirements for reporting
medical device corrections and removals
to FDA.

2
 Contents
 Scope of 21 CFR 806
 When to Report
 Who must Report
 Why Reporting is required
 What must be Reported
 How to Report
 Additional Questions
 Expansion of Corrections and Removals
 Liability
 Records
 Public Disclosure

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 Requirements under
21 CFR 806
 21 CFR 806.1 - Scope
 Section519(f) of the Federal Food, Drug,
and Cosmetic Act (the act) requires
device manufacturers and importers to
report promptly ((within
within 10 working
days of initiation
initiation)) to the Food and
Drug Administration (FDA) certain actions
concerning device corrections and
removals,
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 Requirements under
21 CFR 806
 21 CFR 806.1 cont’d
cont’d
 andto maintain records of all
corrections and removals regardless
of whether such corrections and
removals are required to be reported
to FDA.

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When Do We Have to Report a
Correction or Removal to FDA?
 21 CFR 806.10(b)
 Themanufacturer or importer shall
submit any required report within 1010--
working (business) days of initiating such
correction or removal.

WITHIN 10 BUSINESS DAYS

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 Who Must Report Corrections
and Removals to FDA?
 All
Manufacturers and Importers
are required to report corrections
and removals to FDA.

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 Who Must Report Corrections
and Removals to FDA?
 Manufacturer –
Any person who manufactures, prepares,
propagates, compounds, assembles, or processes
a device by chemical, physical, biological, or other
procedures. The term includes any person who:

(1) Repackages or otherwise changes the

container, wrapper, or labeling of a device in
furtherance of the distribution of the device
from the original place of manufacture to the
person who makes final delivery or sale to the
ultimate user or consumer; or

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 Who Must Report Corrections
and Removals to FDA?
 Manufacturer –

(2) Initiates specifications for devices that

are manufactured by a second party for
subsequent distribution by the person
initiating the specifications; or…
or…

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 Who Must Report Corrections
and Removals to FDA?
 Manufacturer –

(3) Manufactures components or

accessories which are devices that are
ready to be used and are intended to be
commercially distributed and are
intended to be used as is, or are
processed by a licensed practitioner or
other qualified person to meet the needs
of a particular patient.

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 Who Must Report Corrections
and Removals to FDA?
 Importer –
For the purposes of 21 CFR 806, an
importer is any person who imports a
medical device into the United States.

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 Who Must Report Corrections
and Removals to FDA?
 21 CFR 806.10(a)
 Each device manufacturer or importer
shall submit a written report to your FDA
district office of any correction or removal
of a device initiated by such
manufacturer or importer if the correction
or removal was initiated:

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Who Must Report Corrections
and Removals to FDA?
 21 CFR 806.10(a)(1) and (a)(2):
1. To reduce a risk to health posed by the
device; or
2. To remedy a violation of the act caused
by the device which may present a risk
to health

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What Must We Include in the
Report?
1. Correction or Removal Report Number
2. Manufacturer or Importer Information
3. Device Identification
4. Marketing Status
5. Model
6. Manufacturer Information
7. Event Description
8. Illnesses or Injuries

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What Must We Include in
the Report?
6. Quantities
7. Date of Manufacture and Distribution
8. Consignees
9. Communications
10. Statement if missing any above information

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 1. Report Number
 21 CFR 806.10(C)(1)
 The seven digit registration number of
the entity responsible for submission of
the report of corrective or removal action
(if applicable), the month, day, and year
that the report is made, and a sequence
number (i.e., 001 for the first report, 002
for the second report, 003 etc.), and the
report type designation "C" or "R".
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 1. Report Number
 Report Numbers must be in this
format:

1234567-MM/DD/YYYY-001-R
1234567-MM/DD/YYYY-001-R

Registration # Date Report # C or R

C = Correction
R = Removal
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 1. Report Number
 If
your firm does not have a
Registration Number, enter seven
zeros in place of the Registration
Number, like this:

0000000-MM/DD/YYYY-001-R
0000000-MM/DD/YYYY-001-R

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 1. Report Number
 If your firm submits more than one report to
FDA, change the report number to reflect
how many reports have been submitted, like
this:
Removal 1 – 1234567-MM/DD/YYYY-001-R
1234567-MM/DD/YYYY-001-R
Removal 2 – 1234567-MM/DD/YYYY-002-R
1234567-MM/DD/YYYY-002-R

Correction 1 – 1234567 -MM/DD/YYYY-001-C

1234567-MM/DD/YYYY-001-C
Correction 2 – 1234567-MM/DD/YYYY-002-C
1234567-MM/DD/YYYY-002-C

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 2. Manufacturer or Importer
Information
 21 CFR 806.10(C)(2)
 The report should contain the name,
address, and telephone number of the
manufacturer or importer, and the name,
title, address, and telephone number of
the manufacturer or importer
representative responsible for conducting
the device correction or removal.

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 2. Manufacturer or Importer
Information
 Like this
this::
Device Manufacturer, Inc
123 Main St
Anytown
Anytown,, CA 90210
(949) 555 -1212
555-1212

Firm Representative:
Jane Smith, Title
123 Main St
Anytown
Anytown,, CA 90210
(949) 555 -1212 x 123
555-1212
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 3. Device Identification
 21 CFR 806.10(C)(3)
 The brand name and the common name,
classification name, or usual name of the
device and the intended use of the
device.

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 3. Device Identification
 Be very specific with device name.

This is not acceptable:

Name of Device:
Pump, White

This is acceptable
Name of Device: XYZ Dandy Pump
Pump, Infusion, Implanted, Programmable
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 3. Device Identification
 Be very specific with the Intended Use.
Reflect the FDA cleared/approved
Intended Use.

This is not acceptable:

Pumps fluid

This is acceptable:
Intended for use in parenteral, enteral, and
epidural therapies and the administration of
whole blood and blood products.
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 4. Marketing Status of Device
 21 CFR 806.10(C)(4)
 The report should contain the marketing
status of the device, i.e., any applicable
premarket notification number, premarket
approval number, or indication that the
device is a pre -amendments device, and
pre-amendments
the device listing number.

For Example:
510(k) #: K111234
PMA #: P111234
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 5. Model
 21 CFR 806.10(C)(5)
 The report should contain the model,
catalog, or code number of the device
and the manufacturing lot or serial
number of the device or other
identification number.

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 6. Manufacturer’s Name
Manufacturer’s
 21 CFR 806.10(C)(6)
 Thereport should contain the
manufacturer's name, address, telephone
number, and contact person if different
from that of the person submitting the
report.

For example, a firm may be

manufacturing at a different site than the
site reporting to FDA. Make it clear in
the report who is recalling and who is
manufacturing
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 6. Manufacturer’s Name
Manufacturer’s
For Example:

Recalling Firm
Device Recaller
Recaller,, Inc
123 Main St
Anytown
Anytown,, CA 90210
(949) 555 -1212
555-1212

Manufacturer
Device Manufacturer, Inc
123 Stone Ave
Devicetown
Devicetown,, FL 33756
(800) 555-1212
555-1212

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 7. Event Description
 21 CFR 806.10(C)(7)
 The report should contain a description of
the event(s
event(s)) giving rise to the information
reported and the corrective or removal
actions that have been, and are expected
to be taken.

 Includeas much relevant information as

possible, be clear in terms of what has
been done as well as what will be done.
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 8. Illnesses or Injuries
 21 CFR 806.10(C)(8)
 The report should contain information
about any illness or injuries associated
with the use of the device. If applicable,
identify any Medical Device Reports
(MDRs) submitted to FDA for these
illnesses or injuries.

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 9. Quantity of Devices
 21 CFR 806.10(C)(9)
 The total number of devices
manufactured or distributed subject to
the correction or removal and the
number in the same batch, lot, or
equivalent unit of production subject to
the correction or removal.

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 9. Quantity of Devices
For Example
Example::
Total Qty Manufactured: 1,000 Pumps
Lot 1 – 250
Lot 2 – 250
Lot 3 – 250
Lot 4 – 250

Please also include the number distributed:

Total Qty Distributed: Lots 1 and 2 = 500
Pumps 32
 10. Date of Manufacture or
Distribution
 21 CFR 806.10(C)(10)
 Thereport should contain the date of
manufacture or distribution and the
device's expiration date or expected life.

For Example
Example::

Manufactured 01/01/2013 – 04/01/2013

Expiration date – 4 years from date of

manufacture
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 11. Consignees
 21 CFR 806.10(C)(11)
 Yourreport should contain the names,
addresses, and telephone numbers of all
domestic and foreign consignees of the
device and the dates and number of
devices distributed to each such
consignee

NOTE: This data should be accurate since FDA may

contact these consignees to determine your recall
effectiveness.
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 12. Communications
 21 CFR 806.10(C)(12)
 Your report should contain a copy of all
communications regarding the correction
or removal and the names and addresses
of all recipients of the communications
not provided in accordance with
paragraph (c)(11) of this section.

NOTE: If the recall is potentially a Class I Recall,

contact FDA District Recall Coordinator as soon as
possible to provide your report and customer
notification strategy/letter.

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 13. Missing Information?
 21 CFR 806.10(C)(13)
 Ifany required information is not
immediately available, you should provide
a statement to FDA as to why it is not
available and when it will be submitted.

NOTE: FDA takes recalls very seriously and will

follow up with firms submitting incomplete
information; possibly taking Regulatory Actions
against the firm if necessary. These actions may
include Warning Letters, Untitled Letters, Civil
Money Penalties, etc.
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 Requirements under 21 CFR
806
 21 CFR 806.10(f)
 No report of correction or removal is required
under this part, if a report of the correction or
removal is required and has been submitted
under parts 803 – Medical Device Reporting
or 1004 – Repurchase, Repairs, or
Replacement of Electronic Products.

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 How do We Report a
Correction or Removal to FDA?
 21 CFR 7.46
 You are requested to report corrections or removals to
your FDA District Recall Coordinator as soon as
possible.
 21 CFR 806.10(b)
 Remember, you are required to report within 10
business days after initiating such correction or
removal.

 You may find your recall coordinator here:

www.fda.gov/
Safety/Recalls/IndustryGuidance/ucm129334.htm
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 Failure to Comply
 SEC. 502.(t) (21 U.S.C. 352)
 A device shall be deemed to be misbranded –
 If it is a device and there was a failure or refusal
 to comply with any requirement prescribed under section
518 – [Notification],
 to furnish any material or information required by or
under section 519 – [General Rule of Records and
Reports on Devices] – or
 to comply with a requirement under section 522 –
[Postmarket Surveillance].

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 Additional Questions
 Expansion of correction or removal
 Liability

 Records

 Public Disclosure

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 What if We Expand the
Correction or Removal?
 If, after submitting a report under this
part, a manufacturer or importer
determines that the same correction or
removal should be extended to additional
lots or batches of the same
device …………………………..
device…………………………..

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 What if We Expand the
Correction or Removal?
 ………………
………………..the ..the manufacturer or importer
shall within 10 -working (business) days of
10-working
initiating the extension of the correction or
removal, amend the report by submitting
an amendment citing the original report
number.

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 What if We Expand the
Correction or Removal?
 Your report for the expansion of the
original recall should contain:

1. The original report number

2. All contact information for the
manufacturer or importer as required
under 21 CFR 806.10(c)(2)
3. Any other information that differs from
the original report
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Are We Admitting Liability?

 A report submitted by a manufacturer or

importer under this section (and any
release by FDA of that report or
information) does not necessarily reflect a
conclusion by the manufacturer, importer,
or FDA that the report or information
constitutes an admission that the device
caused or contributed to a death or
serious injury.
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Are We Admitting Liability?

 A manufacturer or importer need not

admit, and may deny, that the report or
information submitted under this section
constitutes an admission that the device
caused or contributed to a death or
serious injury.

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 Exemptions from 21 CFR 806
Requirements
 21 CFR 806.1 cont’d
cont’d
 There are certain actions which are
exempt from the Reporting
requirements under 806

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 Exemptions from 21 CFR 806
Requirements
 Exemptions
1. Changes which improve quality but do
not reduce a risk to health or remedy a
violation
2. Market Withdrawals
3. Routine Servicing
4. Stock Recoveries

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 Exemptions from 21 CFR 806
Requirements
 Exemptions
 Actions taken by device manufacturers or
importers to improve the performance or
quality of a device but that do not reduce
a risk to health posed by the device or
remedy a violation of the act caused by
the device

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 Exemptions from 21 CFR 806
Requirements
 Exemptions
 Market Withdrawals -
A Market Withdrawal is a correction or
removal of a distributed device that
involves a minor violation of the act that
would not be subject to legal action by
FDA or that involves no violation of the
act, e.g., normal stock rotation practices.

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 Exemptions from 21 CFR 806
Requirements
 Exemptions
 Routine Servicing -
Any regularly scheduled maintenance of a
device, including the replacement of parts
at the end of their normal life
expectancy, e.g., calibration, replacement
of batteries, and responses to normal
wear and tear. Repairs of an unexpected
nature, replacement of parts earlier than
their normal life expectancy, or identical
repairs or replacements of multiple units
of a device are not routine servicing.
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 Exemptions from 21 CFR 806
Requirements
 Exemptions
 Stock Recoveries -
The correction or removal of a device
that has not been marketed or that has
not left the direct control of the
manufacturer, i.e., the device is located
on the premises owned, or under the
control of, the manufacturer, and no
portion of the lot, model, code, or other
relevant unit involved in the corrective or
removal action has been released for sale
or use. 51
 Exemptions from 21 CFR 806
Requirements
 IF IN DOUBT –

ASK YOUR DISTRICT

RECALL
COORDINATOR
(DRC)
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 If We Did Not Need to Report
our Correction or Removal,
What Records Do We Keep?
 Each device manufacturer or importer who
initiates a correction or removal of a
device that is not required to be reported
to FDA under 806.10 shall keep a record
of such correction or removal.

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 What Should the Records
Contain?

 Records of corrections and removals not

required to be reported to FDA under
806.10 shall contain the following
information:

1. The brand name, common or usual name,

classification, and product code if known,
and the intended use of the device

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 What Should the Records
Contain?

2. The model, catalog, or code number of the

device and the manufacturing lot or serial
number of the device or other identification
number

3. A description of the event(s

event(s)) giving rise to
the information reported and the corrective
or removal action that has been, and is
expected to be taken.

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 What Should the Records
Contain?
4. Justification for not reporting the correction
or removal action to FDA, which shall
contain conclusions and any follow -ups, and
follow-ups,
be reviewed and evaluated by a designated
person.
 The justification may include a root cause analysis
The

5. A copy of all communications regarding the

correction or removal.

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How Long Should We Keep the
Records?
 The manufacturer or importer shall retain
records required under this section for a period
of 2 years beyond the expected life of the
device
device,, even if the manufacturer or importer has
ceased to manufacture or import the device.

 Records required to be maintained under

paragraph (b) of this section must be
transferred to the new manufacturer or importer
of the device and maintained for the required
period of time
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 FDA Access to Records
 Each device manufacturer or importer
required under this part (21 CFR 806) to
maintain records and every person who is
shall,,
in charge or custody of such records shall
upon request of an officer or employee
designated by FDA and under section
704(e) of the act, permit such officer or
employee at all reasonable times to have
access to, and to copy and verify, such
records and reports
reports..
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 FDA Access to Records
 It is imperative that you keep accurate
records of any correction or removal
undertaken by your firm.

 FDA can and may inspect these records.

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 Will FDA Make Our Report
Public?
 Any report submitted under this part is
available for public disclosure in
accordance with part 20, Chapter 1 of
Title 21 of the Code of Federal
Regulations.

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 Will FDA Make Our Report
Public?
 Before public disclosure of a report, FDA
will delete from the report:

1. Any information that constitutes trade

secret or confidential commercial or
financial information under 20.61 of
this chapter; and

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 Will FDA Make Our Report
Public?
2. Any personnel, medical, or similar
information, including the serial numbers of
implanted devices, which would constitute a
clearly unwarranted invasion of personal
privacy under 20.63 of this chapter or 5
U.S.C. 552(b)(6); provided, that except for
the information under 20.61 of this chapter
or 5 U.S.C. 552(b)(4), FDA will disclose to a
patient who requests a report all the
information in the report concerning that
patient

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 Will FDA Make Our Report
Public?

 FDA has an obligation to protect the public

health by providing to consumers accurate
and timely information which may
negatively impact their health.

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 In Summary
 In summary, the following topics were
presented:
 Who must report corrections and removals
 The requirements under Title 21 of the Code of
Federal Regulations, Part 806
 Information regarding the contents of an 806
Report
 A web link to find the FDA District Recall
Coordinator to whom you should send your 806
reports

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 Thank You
If you have further questions regarding reporting
requirements, you may contact:

 FDA District Recall Coordinator

www.fda.gov/
Safety/Recalls/IndustryGuidance/ucm129334.htm
or
CDRH -Division of Small Manufacturers,
CDRH-Division
International and Consumer Assistance (DSMICA)
 1 -800-638-2041
1-800-638-2041
 301 -796-7100
301-796-7100
 dsmica@fda.hhs.gov
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